1. The Field of the Invention
This invention relates to valves. More specifically, this invention relates to valves employed in manifolds used during administration of medical liquids to a patient.
2. The Relevant Technology
During angiography and angioplasty procedures (hereinafter, "angio procedures"), a fluids administration set may be employed. During such an angio procedure, a femoral artery site or other site is prepared by a physician. Site preparation is typically performed by injecting a local anesthetic at the femoral artery penetration site to numb the area. An introducer is then used to puncture the epidermis and arterial wall thereunder so as to access the femoral artery. A guide wire is introduced into the artery, and the introducer is removed.
After the removal of the introducer, a sheath is typically inserted into the area where the introducer was removed. The sheath protects the femoral artery site during the angio procedure. A guiding catheter is then slid through the sheath and femoral artery and the catheter is advanced to the heart of the patient. After the catheterization of the patient, a fluids administration set is attached to the guiding catheter for administration of fluids during the angio procedure.
Fluids administration set 10 of FIG. 1 is a depiction of a fluids administration set which is typical in angio procedures. As to the typical aspect of such procedures, FIG. 1 will now be explained. Fluids administration set 10 features a syringe 12 connected to a catheter manifold 14. Catheter manifold 14 has a manifold fluid tube 16 for moving a variety of pressure laden fluids through catheter manifold 14.
Manifold 14 has a proximal end 18 and a distal end 20. At distal end 20 of manifold 14, opposite syringe 12, is a rotating adaptor 22 which connects a catheter (not shown) to manifold 14 and through which various fluids pass intracorporeally to a patient undergoing an angio procedure.
Saline solution occlusion stopcock 24 selectively directs fluid between manifold tube 16 and saline solution port 26. Saline solution port 26 is in fluid communication with a saline solution container (not shown) such as a saline solution bag. Port 26 allows access to saline for flushing the aforementioned catheter with saline so as to clear the catheter of any particulate or thrombosis. Pressure monitor occlusion stopcock 28 selectively directs fluid between manifold fluid tube 16 and pressure monitor port 30.
Stopcocks 24, 28, each have a handle thereon which is rotated to direct the flow of pressure laden fluids through catheter manifold 14. In order to operate a stopcock to stop a fluid from passing through the stopcock, the associated handle is turned toward a fluid line so as to point at the fluid line. When so pointed, the stopcock valve closes and prevents fluid in the pointed at line from passing through the stopcock. In FIG. 1, each of the stopcock handles are pointed toward respective ports. This permits fluid traveling through manifold fluid tube 16 to pass through each of the two stopcocks, but not through ports 26 and 30.
Pressure monitor port 30 is in fluid communication with a pressure monitor (not shown) which includes a transducer which measures different pressures in the catheterized heart. In order for this pressure measurement to take place, the handle 31 of pressure monitor occlusion stopcock 28 must be turned to point toward syringe 12 so as to permit fluid to pass from the catheter through port 30 and on to the transducer for sensing and measurement of the heart pressures.
At a proximal end 18 of manifold 14, a check valve 32 is coupled between syringe 12 and manifold 14. A tube (not shown) communicates contrast media from a contrast media fluid source (not shown), to port 34 of check valve 32. Upon retraction of plunger 36 of syringe 12, the contrast fluid selectively flows through valve 32, into syringe 12. Upon compression of syringe 12, the contrast fluid then flows through valve 32, manifold 14 and a catheter coupled to manifold 14 and then into the circulatory system of the patient. When contrast media is injected into the coronary arteries for fluoroscopy, the contrast is visible within the patient and aids in diagnostics.
In order to inject contrast media into the patient, the handles of stopcocks 24, 28 should be pointed toward respective ports 26, 30 as illustrated in FIG. 1 so that contrast media ejected from syringe 12 will pass through both valve 32 and manifold 14. Upon compression of plunger 36 into fluid filled barrel 38, fluid is dispelled into the patient through manifold tube 16 and via the intracorporeally inserted catheter (not shown).
Check valve 32 has a main valve chamber 40, a fluid inlet port 42 coupled to main valve chamber 40, and a fluid outlet port 44 coupled to main valve chamber 40. Fluid inlet port 42 is coupled to syringe 12 through the use of interlocking male and female Luer lock members. Outlet port 44 is tapered so as to be pressed into inlet port 46 of fluid tube 16 and secured thereto through the use of an adhesive.
One advantage of check valve 32 is that the practitioner is not required to turn a stopcock in order to selectively allow fluid to flow therethrough. Instead, the practitioner is merely required to retract plunger 36 of syringe 12, thereby creating a negative pressure within barrel 38, which causes fluid to flow through port 34 from a source of contrast fluid, and into syringe 12. Then, also without turning a stopcock, the practitioner can compress plunger 36 into syringe 12, thereby releasing fluid into the circulatory system of the patient. Thus, contrast fluid can be injected into the patient's circulatory system by retracting plunger, then compressing plunger, rather than requiring the opening of a stopcock to allow fluid into syringe 12 and turning a stopcock to deliver fluid to manifold 14.
However, one difficulty with check valve 32, is that outlet port 44 of valve 32 is particularly susceptible to breakage and other damage during the use of system 10. As the practitioner manipulates syringe 12 in order to fill syringe 12 with fluid and dispel fluid therefrom, the practitioner must grip system 10 tightly and often push with significant force against plunger 36 of syringe 12 in order to force dispel within syringe 12 into the circulatory system of the patient.
As the practitioner compresses fluid within syringe 12 by inserting plunger 36 with such force into barrel 38, the practitioner often holds manifold 14 in one hand. The practitioner thus presses against plunger 36 with one hand while holding manifold 14 in another hand. Consequently outlet port 44 of valve 32 presses with significant force against inlet port 46 of manifold 14, stressing the connection between outlet port 44 and inlet port 46 and particularly stressing outlet port 44.
In addition, as the practitioner presses against plunger 36 with one hand while holding manifold 14 with another hand, it is not uncommon for the practitioner to bend syringe 12 at least slightly with respect to manifold 14. This bending action places particular stress on outlet port 44 of valve 32, which is positioned between syringe 12 and manifold 14.
The bending and compressive forces on outlet port 44 of valve 32 can break, crack or otherwise damage outlet port 44. Such damage can result in the loss of fluid from system 10 during an angioprocedure and may require replacement of valve 32 or both valve 32 and manifold 14 during such an angioprocedure. Such loss of fluid and replacement is inconvenient and time consuming and may require decoupling and recoupling of a variety of different fluid sources and systems before the procedure can be resumed.